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RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill the tumor cells. Combining chemotherapy with interleukin-12 may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining liposomal doxorubicin with interleukin-12 in treating patients who have AIDS-related Kaposi's sarcoma.

Determine the time to response and the number of complete responses in patients treated with this regimen.

Determine the progression-free survival of patients treated with this regimen.

Provide pilot information on the ability of interleukin-12 to maintain major responses induced with paclitaxel salvage therapy in patients with aggressive or life-threatening KS after treatment failure with doxorubicin HCl liposome and interleukin-12.

Determine the effect of this regimen on CD4 counts and viral load in these patients.

OUTLINE: Patients receive doxorubicin HCl liposome (LipoDox) IV over 30 minutes once every 3 weeks for a total of 6 doses. Beginning concurrently with the initiation of LipoDox, patients also receive interleukin-12 (IL-12) subcutaneously twice weekly (at least 3 days apart) for up to 3 years.

Patients with refractory disease are transferred to the paclitaxel salvage therapy regimen comprising paclitaxel IV continuously on days 1-4 once every 3 weeks until a major response is achieved. Beginning concurrently with the initiation of paclitaxel salvage therapy, patients also receive IL-12 as above for up to 3 years.

Treatment continues in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response may discontinue IL-12 administration. If necessary, IL-12 treatment may resume at a later time.

Patients are followed at 4 weeks.

PROJECTED ACCRUAL: A total of 24-36 patients will be accrued for this study within 2-4 years.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed Kaposi's sarcoma (KS)

HIV positive

Evaluable disease involving the skin and/or viscera

At least 5 lesions not previously treated with local therapy if restricted to the skin

No other prior or concurrent malignancy except squamous cell carcinoma in situ of the cervix or anus, completely resected basal cell carcinoma, or malignancy in complete remission for at least 1 year from the time a response was first documented

No severe or life-threatening infection within the past 2 weeks

No abnormality that would be scored as grade 3 toxicity except lymphopenia or direct manifestations of KS

No known hypersensitivity to interleukin-12 (IL-12) or other compounds known to cross-react with IL-12

No other medical condition that would preclude study entry

PRIOR CONCURRENT THERAPY:

Biologic therapy:

More than 2 weeks since prior cytokines or colony-stimulating factors other than epoetin alfa, filgrastim (G-CSF), or sargramostim (GM-CSF)

No prior combination interleukin-12 and doxorubicin HCl liposome except for patients previously treated on this protocol who are being enrolled for paclitaxel salvage therapy

No concurrent immunomodulatory agents

No concurrent cytokines except epoetin alfa or G-CSF

Chemotherapy:

See Disease Characteristics

See Biologic therapy

At least 3 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas)

More 6 months since prior suramin

No other concurrent cytotoxic chemotherapy

Endocrine therapy:

More than 2 months since prior systemic glucocorticoid steroids at doses sufficient to affect immune response (e.g., more than 20 mg of prednisone for more than 1 week)

Concurrent replacement glucocorticoid therapy allowed

No other concurrent systemic glucocorticoid therapy

Radiotherapy:

Not specified

Surgery:

Not specified

Other:

Concurrent antiretroviral therapy required

No other concurrent anti-KS therapy

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00020449